A specified clinical study for safety and usefulness of negative pressure closure for the stabilization of skin graft in wide or muscle-exposing defects - NPSG study

akamura Yoshiyuki0 个研究点目标入组 7 人2018年12月25日

适应症Skin defect Skin defect, skin graft

概览

阶段: 2 期
干预措施: 未指定
疾病 / 适应症: Skin defect
发起方: akamura Yoshiyuki
入组人数: 7
状态: 已完成
最后更新: 2年前

概览研究者入排标准结局指标相似试验

概览

简要总结

In this study, there were no cases with adverse events associated with the negative pressure closure system. The mean survival rate of the skin graft 7 and 10 days after operation was 98.7% (range: 97-100) and 96.5% (range: 89.4-98.4), respectively. The mean time from initiatoin of the skin graft stabilization to the end of the operation was 12.9 minutes (range: 10.7-19.5), suggesting safety and usefulness of negative pressure closure system for graft stabilization.

注册库

who.int

开始日期

2018年12月25日

结束日期

2020年5月10日

最后更新

2年前

研究类型

Interventional

性别

All

研究者

发起方

akamura Yoshiyuki

入排标准

入选标准

•Patients with defects in the trunk and extremities of \>10 cm in size, or with muscle exposure.

排除标准

•Defects with contraindication for negative pressure closure (defects with exposure of main vessels, organs or nerves. Defects with fissures connected with organs or untested fissures. Defects with liquorrhea or digestive system fistula, which are suspected to become severer by negative pressure closure. Defects with necrosis, osteomyelitis with osteonecrosis or apparent malignant tumor.) Dialysis patients, diabetic patients (HbA1c\>8%), patients with systemic steroid therapies (\>prednisolone 20mg/ day). Defects of which the fixation by negative pressure closure is difficult because of hubby surface of surrounding tissues. Defect with bone exposure. Cases in which the devices are possible to be broken because of difficulty of keeping the patient at rest. A patient who shows more than 2 skin defects that fit the inclusion criteria.

结局指标

主要结局

未指定

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